MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; NASAL TUBING

Model Number	BC190-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Section g4: no 510(k) number was included due to the subject device being exempt from pma pathway to regulatory approval.Method: the subject device bc190-05 flexitrunk infant nasal tubing was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the distributor.Results: visual inspection of the provided photograph revealed that one tubing of the bc190 flexitrunk infant nasal tubing was torn.Conclusion: we are unable to determine the exact cause of the reported event.All flexitrunk nasal tubing are visually inspected, and pressure tested before leaving the production line, those that fail are rejected.The subject flexitrunk nasal tubing would have met the requirements at the time of production.Our user instructions which accompany the bc190 flexitrunk nasal tubing state: "use caution when positioning or disconnecting to the infant interface.Avoid excessive pull forces, sharp objects, and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the bc190 flexitrunk nasal tubing.
Event or Problem Description
A distributor in china on behalf of a healthcare facility reported that the tubing of a bc190-05 flexitrunk infant nasal tubing was broken.There was no reported patient involvement.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL TUBING
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22974926
• Report Number: 9611451-2025-00830
• Device Sequence Number: 8973108
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2103237503(11)240715(17)270715
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC190-05
• Device Catalogue Number: BC190-05
• Device Lot Number: 2103237503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown